BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENSITE VELOCITY¿ DWS7 V.5.0

    MDR report key: 8678500 · Received June 7, 2019

    Report

    Report Number
    2184149-2019-00104
    Event Type
    Injury
    Date Received
    June 7, 2019
    Date of Event
    May 14, 2019
    Report Date
    September 16, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DQK
    PMA / PMN Number
    K172396
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THE COMPUTER WAS POWERED ON AND SUCCESSFULLY BOOTED TO THE APPLICATION MENU. A TEST UNIT REMOTE MONITOR WAS CONNECTED AND DISPLAYED AS INTENDED. TACTILE MOVEMENT AT THE CONNECTOR CONFIRMED THE CONNECTION WAS FIRM AND CAUSED NO INTERMITTENT CONNECTION ON THE REMOTE MONITOR. REVIEW OF THE SYSTEM LOGS IDENTIFIED NO ANOMALIES AND THE FIELD REPORTED EVENT WAS NOT REPRODUCIBLE AS THE REMOTE MONITOR MAINTAINED DISPLAY OF THE SYSTEM DISPLAY. FURTHER INSPECTION VERIFIED A SUCCESSFUL MEMORY AND HARD DISK DIAGNOSTIC TEST. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE REVIEW DETERMINED THE PROCESS WAS PERFORMED AND COMPLETED IN ACCORDANCE WITH ABBOTT SPECIFICATIONS AND PROCEDURES. BASED ON THE INVESTIGATION PERFORMED AND THE INFORMATION AVAILABLE, THE CAUSE OF THE REPORTED DISPLAY ISSUE AND SUBSEQUENT PROCEDURE CANCELLATION COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN A SUBSEQUENT SUBMISSION.

    Description of Event or Problem · 1

    DURING DEVICE PREPARATION FOR AN ATRIAL FLUTTER PROCEDURE, THE IMAGE ON THE SYSTEM WAS UNABLE TO BE OBSERVED ON THE REMOTE MONITOR AND THE PROCEDURE WAS CANCELLED. TROUBLESHOOTING WAS ATTEMPTED AND THE CONNECTIONS WERE VERIFIED WITH NO RESOLUTION SO THE PROCEDURE WAS RESCHEDULED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT DUE TO THE CANCELLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473226 ENSITE VELOCITY¿ DWS7 V.5.0 ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM DQK ST. JUDE MEDICAL, INC. 100145077 5616774

    Patients

    Seq Age Sex Outcome Treatment
    1 Other